NCT00682344

Brief Summary

Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

4 years

First QC Date

May 16, 2008

Last Update Submit

August 27, 2014

Conditions

Surgical Pathology of the Leg or the Foot.

Outcome Measures

Primary Outcomes (1)

  • The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients.

    24 months

Secondary Outcomes (1)

  • Appreciation, by the anaesthetist in charge of the patient, of the quality of the "surgical" analgesia during the surgery by: very effective, effective, ineffective. Measure of the delay of appeal of the first one bolus of morphine.

    24 months

Interventions

LevobupivacaïneDRUG

1,75mg/kg

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Surgical pathology of the leg or the foot with garot tyre of thigh
  • Age included between 6 months and 12 years
  • Status ASA I or II

You may not qualify if:

  • Bilateral or one-sided surgical gesture realized without garot tyre
  • Cutaneous infection in the point of draining
  • Clinical confusion of the coagulation
  • Allergy informed in the local anesthesics of amino-acid class
  • Evolutionary neurological pathology of the operated limb
  • Renal, respiratory, cardiac or hepatic insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique

Marseille, 13005, France

Location

Study Officials

  • Frédéric LACROIX, MD

    ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 22, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

FR(1)